Director, Clinical Affairs (Hybrid - Sunnyvale)

Added
14 days ago
Type
Full time
Salary
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Related skills

gcp regulatory affairs medical devices clinical trials ema

๐Ÿ“‹ Description

  • Develop and drive the clinical strategy for current and future products, ensuring alignment with
  • Lead the planning, design and execution of clinical trials that drive product validation, adoption
  • Serve as the primary clinical interface with Regulatory Affairs, R&D, Go-to-Market and
  • Lead the selection and management of Key Opinion Leaders (KOLs) to advise on study design, clinical
  • Ability to manage multiple projects simultaneously and to solve problems proactively in a
  • Represent the company at conferences and be the primary point of contact for key opinion leaders

๐ŸŽฏ Requirements

  • Bachelorโ€™s degree in a life science, engineering, or related discipline. An advanced degree (Ph.D.
  • Minimum of 8+ years of progressive experience in Clinical Research/Affairs within the medical
  • Proven track record in designing, executing, and reporting pivotal, randomized clinical trials for
  • Deep, working knowledge of FDA regulations (CFR Title 21), ICH-GCP, and ISO 14155 (Clinical

๐ŸŽ Benefits

  • Performance-based incentive compensation (varies by role)
  • Equity opportunities
  • 100% Employer paid Health Benefits for Employees
  • 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
  • 100% paid Life and Long-Term Disability Insurance
  • 401(k) with a generous company match
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